[Translation] To evaluate the single-center, randomized, open-label, single-dose ( 50 mg) four-cycle, two-sequence, fully replicated crossover bioequivalence study
主要研究目的:研究空腹和餐后状态下单次口服受试制剂匹维溴铵片(规格:50 mg,郑州泰丰制药有限公司生产)与参比制剂匹维溴铵片(Dicetel®,规格:50 mg,Mylan Laboratories SAS生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂匹维溴铵片(规格:50 mg)和参比制剂匹维溴铵片(Dicetel®,规格:50 mg)在健康受试者中的安全性。
[Translation] Main research purpose: To study the single oral administration of the test preparation pinaverium bromide tablets (specification: 50 mg, produced by Zhengzhou Taifeng Pharmaceutical Co., Ltd.) and the reference preparation pinaverium bromide tablets (Dicetel®, specifications) in fasting and postprandial states. : 50 mg, produced by Mylan Laboratories SAS) in healthy subjects to evaluate the bioequivalence of the two oral formulations in the fasting and postprandial states.
Secondary study purpose: To evaluate the safety of the test preparation pinaverium bromide tablets (strength: 50 mg) and the reference preparation pinaverium bromide tablets (Dicetel®, strength: 50 mg) in healthy subjects.